The Senate Judiciary Committee moved six bills forward this past week that address prescription drug pricing, several of which would overhaul the patent system. Drug patent reform has been on hold for years, despite having broad bipartisan support. Is this time different? Is the 119th Congress ready to act? Perhaps, given the sense of urgency among constituents and policymakers. But in light of the recent history of failure to pass changes, it’s not a done deal.
At 29%, Congress has a much worse approval rating than the executive branch, whether under former President Biden or President Trump. This could have something to do with legislators not getting things done. On healthcare, and specifically prescription drug policy, Congress has been known to punt on reforms, including initiatives with respect to Pharmacy Benefit Managers and drug patents. When I think about how many times such proposed reforms have been postponed, in my head I hear the refrain “still waiting” in the Talking Heads song, Cross-eyed and painless. Some blame lobbyists. Perhaps they are the culprits. But there’s also a lot of inertia in the Senate and the House.
It’s hard to find bipartisan consensus among lawmakers in Congress these days. But there’s been widespread agreement on calls for pharmaceutical patent reform for a while. The steep prices of some brand-name drugs in the United States may in part owe to tactics used by pharmaceutical manufacturers to extend their monopoly pricing power and obstruct cheaper generics and biosimilars from entering the market.
Politically, there’s agreement across the aisle. Former Food and Drug Administration Commissioner, Scott Gottlieb, a Trump appointee, proclaimed in 2018 the need to “end the shenanigans” that prevent generic and biosimilar products from reaching the market. Former Federal Trade Commissioner under Biden, Lina Khan, chimed in at one point, accusing firms of “improper or inaccurate patent listings … that keep brand name prices artificially high.”
David Mitchell, founder of Patients For Affordable Drugs NOW and a cancer patient, has testified several times over the years before the Senate Judiciary Committee about what he views as anticompetitive tactics deployed by drug companies to extend monopolies on branded products.
And the Initiative for Medicines, Access & Knowledge, a nonprofit organization that advocates drug patent reform, says that “excessive” use of the patent system keeps the prices of medications at “exorbitant” levels, at the expense of American patients.
According to Bloomberg News, between 2005 and 2015, 74% of new drug patents issued were for drugs already on the market. And of the approximately 100 best-selling drugs examined in a separate study covering roughly the same time period, nearly 80% received an additional patent to extend their monopoly period beyond what was originally intended. A STAT News piece published this week pointed to the lengthy monopolies as a cause of high drug costs.
The patent system is meant to reward innovation by permitting drug companies to sell new medications on the market and barring other manufacturers from making generic versions for a set period of time. Once the patent expires, generics are allowed on the market, often at a substantially lower list price than the brand-name drug. In defending intellectual property rights, the pharmaceutical industry maintains that patent reform isn’t needed. It cites the fact that more than 90% of prescriptions in the U.S. are for generics or biosimilars.
But drugmakers often extend their patents by making small tweaks to the drugs, sustaining their monopolies for several years. Legal experts refer to this tactic as “evergreening.”
Democratic and Republican Senators have repeatedly debated and taken steps aimed at curbing what they view as abuses of the system, ways in which drug manufacturers manipulate the patent system. Legislators wish to foster a more competitive market in which generics and biosimilars have a better chance of earlier entry.
With the strong bipartisan support cited, it’s no surprise that Axios reported this week that the Senate Judiciary Committee advanced six bills addressing drug pricing, several of which would revamp the patent system and target what lawmakers call “anti-competitive practices.”
The legislation included a bill addressing “patent thickets” and another dealing with “product hopping.” Product hopping is when a company switches a patient population from a branded product whose patent is expiring and therefore facing imminent competition to a different formulation of the original drug that has a later expiring patent. A patent thicket references the numerous patents drug companies may file to create hurdles to market entry for prospective generic or biosimilar competitors.
Two other bills that have now moved forward aim to improve access to generic drugs, with one limiting “pay for delay” deals and the other deterring drug manufacturers from filing what critics call “sham citizen petitions” that may impede generic drug approvals.
But will this time be any different from efforts we’ve seen in the past? There’s reason to be skeptical. Late last year, the Senate Judiciary Committee again put off voting on two bipartisan drug patent reform bills in the 118th Congress. This could have been because the legislative proposals didn’t go far enough, according to the generic drug and patient advocacy lobbies. Or maybe the bills went too far from the viewpoint of trade groups defending branded manufacturers.
What’s noteworthy is that in this Congress the Committee has voted to advance their plans, re-introduced as two separate bills. Maybe this time around enactment of meaningful changes is imminent. Time will tell.
